elafibranor

Details

Generic Name:
elafibranor
Project Status:
Pending
Therapeutic Area:
Primary biliary cholangitis (PBC)
Manufacturer:
Ipsen Biopharmaceuticals Canada Inc.
Call for patient/clinician input open:
Brand Name:
TBC
Project Line:
Reimbursement Review
Project Number:
SR0865-000 
Call for patient/clinician input closed:
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Ipsen Biopharmaceuticals Canada Inc. requests that elafibranor be funded as per the anticipated Health Canada indication. 
Fee Schedule:
Pending
Indications:
Elafibranor is anticipated to be approved by Health Canada for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA.
Anticipated Date:
  1. The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of Canada's Drug Agency. Reimbursement criteria from Canada's Drug Agency will be documented in the final recommendation, if applicable.